Quality Control Product Specialist
Streck Provides:
- A challenging, safe and rewarding work environment.
- No night or weekend shifts.
- Excellent work life balance.
- Affordable, high-quality apartments for employees.
- Market competitive pay.
- Comprehensive and inclusive benefits.
- Great team environment.
- On and off campus career development opportunities.
Summary of Responsibilities:
The Quality Control Product Specialist is responsible for inspecting, analyzing, approving, and monitoring the integrity and fitness of products to ensure quality, stability, and customer satisfaction. The Quality Control Product Specialist is responsible for producing accurate products associated with production applications: assays, electronic assay files and certificates. Other responsibilities of the Quality Control Product Specialist include proactive interdepartmental communication regarding product performance issues, cooperatively working to resolve product issues, and maintaining compliance to the Streck Quality System. Also, the Quality Control Scientist is responsible for performing duties assigned by QC management.
Essential Duties and Functions:
- Organize, schedule, perform, and evaluate performance characteristics and stability of assigned products during all applicable stages including Pretest, Prefill, Open Vial Stability, Value Assignment, and Closed Vial Stability in accordance to work instruction.
- Develop, maintain, and utilize appropriate data analysis tools to evaluate and predict product performance attributes.
- Maintain QC data in LabVantage and other applicable database programs.
- Assemble, analyze, and value assign instrument specific product assay values utilizing in-house instrumentation and referee data.
- Exhibit proficiency in the operations and functionality of instruments associated with assigned products.
- Develop product reports such as assays, electronic assay files and certificates in an accurate and timely manner.
- Correspond with Technical Services, Product Managers, R&D, Manufacturing, Executive Management, Quality Assurance, Private label accounts, referees and others as required.
- Proof assays, electronic assay files, inserts, artwork, labels, and certificates for accuracy.
- Complete lot file records in accordance to quality system requirements.
- Identify, document, and investigate product performance issues.
- Participate in whole blood calibration verification of instruments.
- Perform other duties as assigned by QC Manager and/or Supervisor.
Position Requirements:
- High school diploma or GED level education with relevant experience required. Bachelor’s degree in science, mathematics, statistics, or related discipline or associate degree with relevant experience strongly preferred.
- Must possess a knowledge base consisting of quality principles and standards, data analysis, statistical analysis, and continuous improvement.
- Demonstrated previous applicable, steady work history with acceptable performance.
Technical Competencies:
- Knowledge of operations and methodology of quality instruments.
- Knowledge of and ability to operate machines and equipment such as Hematology, Chemistry and Flow Cytometry Instruments, Pipettes, Microsoft Office Applications, and more.
- Ability to perform general and complex mathematical calculations.
- Ability to troubleshoot minor instrument problems.
- Ability to review data and detect statistical abnormalities.
- Ability to anticipate potential product problems and effectively participate in problem analysis resolution.
- Ability to analyze existing problems and recommend corrective action.
- Ability to multi-task and handle multiple priorities.
- Ability to manage time and demonstrate flexibility to deal with changing deadlines and priorities.
Work Environment/Travel Demands:
The work environment is a climate-controlled biological/chemical laboratory. Occasional short durations to cold temperatures inside walk-in coolers. Ability to wear required laboratory clean room clothing (laboratory coats, hair bonnets, and beard covers (as applicable) and other safety/protective equipment (masks, gloves, and/or face shields for example) for up to two and a half hours consecutively. Travel demands for this position are estimated up to 0%. If travel is required, this travel may include customer visits, events/trade shows, and completion of presentations primarily throughout Domestic US or International regions. Employees must comply with all travel recommendations regarding “safe travel” according to company policies and guidelines, and all federal, state, local, and international orders.
Physical and Mental Demands:
Medium work exerting up to 40 pounds of force occasionally, and/or up to 20 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. This also includes standing for up to two and a half hours consecutively, walking, pushing, pulling, lifting, reaching, stooping, fingering, and grasping. Expressing and receiving detailed information through written and oral communication. Also has an ability to make sound, appropriate, and prompt decisions within the guidelines of the role.
**The work environment characteristics and physical demands stated in their respective sections are representative of those necessary to perform the essential functions of the job. Reasonable accommodations will be reviewed and considered. If approved, accommodation may be made to enable individuals with disabilities to perform the essential functions of their assigned role.
The above statements are intended to describe the general nature of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Visit www.streckcareers.com to learn more about Streck and apply for this opportunity.
Streck is an Equal Opportunity/Affirmative Action employer and forbids discrimination against any employee or applicant because of race, color, religion, gender (including pregnancy, gender stereotyping and caregiver status), sexual orientation, gender identity, transgender status, national origin, disability, genetic information, citizenship, marital status or status as a covered veteran in accordance with applicable federal, state and local laws.